Last reviewed 2026-05-27 · How we verify

Diurex (XIPAMIDE)

Phase 2 active Small molecule ✓ Verified May 2026

Diurex (generic name: XIPAMIDE) is a xipamide drug. It is currently in Phase 2 development for Edema, Hypertensive disorder.

Diurex works by inhibiting the sodium-chloride cotransporter in the kidneys.

Diurex, also known as Xipamide, is a small molecule medication. Its exact clinical indications and mechanism of action are not specified in the provided facts, but it is listed as a diuretic.

Likelihood of approval

13.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Cardiovascular Phase 3 risk -2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	XIPAMIDE
Drug class	xipamide
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 2

Mechanism of action

Think of your kidneys like filters that help remove excess fluid from your body. Diurex helps these filters work more efficiently by blocking the reabsorption of sodium and chloride, which leads to increased urine production and reduced fluid retention. This helps to alleviate symptoms of edema and hypertension.

Approved indications

Edema
Hypertensive disorder

Common side effects

Product prescribing error
General physical health deterioration
Product monitoring error
Labelled drug-drug interaction medication error
Dyspnoea
Oedema peripheral
Anaemia
Haematochezia
Lymphatic fistula
Femoral hernia incarcerated
Pancreatic steatosis
Acute kidney injury

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Diurex CI brief — competitive landscape report
Diurex updates RSS · CI watch RSS

Frequently asked questions about Diurex

What is Diurex?

Diurex (XIPAMIDE) is a xipamide drug, indicated for Edema, Hypertensive disorder.

How does Diurex work?

Diurex works by inhibiting the sodium-chloride cotransporter in the kidneys.

What is Diurex used for?

Diurex is indicated for Edema, Hypertensive disorder.

What is the generic name of Diurex?

XIPAMIDE is the generic (nonproprietary) name of Diurex.

What drug class is Diurex in?

Diurex belongs to the xipamide class. See all xipamide drugs at /class/xipamide.

What development phase is Diurex in?

Diurex is in Phase 2.

What are the side effects of Diurex?

Common side effects of Diurex include Product prescribing error, General physical health deterioration, Product monitoring error, Labelled drug-drug interaction medication error, Dyspnoea, Oedema peripheral.

Drug class: All xipamide drugs
Therapeutic area: All drugs in Cardiovascular
Indication: Drugs for Edema
Indication: Drugs for Hypertensive disorder

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing